GYRUS ACMI, INC

GUDID 00821925040953

BULK PACK POLYETHYLENE DRAIN TUBES (50/PK)

Gyrus ACMI, LLC

Tympanostomy tube

• Primary Device ID: 00821925040953
• NIH Device Record Key: efc03bfa-226c-4dc0-91a1-059068d20dc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GYRUS ACMI, INC
• Version Model Number: 140022
• Company DUNS: 007198742
• Company Name: Gyrus ACMI, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925015128 [Package]; Package: [50 Units]; In Commercial Distribution
GS1	00821925040953 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992222

FDA Product Code

• ETD: Tube, Tympanostomy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2024-11-18
• Device Publish Date: 2015-10-24

On-Brand Devices [GYRUS ACMI, INC]

• 00821925040953: BULK PACK POLYETHYLENE DRAIN TUBES (50/PK)
• 00821925008892: Snap-On Connector For Gyrus ACMI Fiberoptic Light Guide